The present invention relates generally to the detection of fluid and/or other material in tissue, and especially, to systems, methods and/or devices for detecting changes in the level of fluid in tissue. In certain embodiments, the systems, methods and/or devices of the present invention detect if fluid level has increased or, has otherwise become abnormal.
The following information is provided to assist the reader to understand the invention disclosed below and the environment in which it will typically be used. The terms used herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the present invention or the background of the present invention. Inclusion of a reference herein, however, is not intended to and does not constitute an admission that the reference is available as prior art with respect to the present invention
Changed, elevated or abnormal fluid levels in living tissue can result from a number of physiological conditions. For example, edema is an abnormal accumulation of watery fluid in the intercellular spaces of connective tissue. Edematous tissues are swollen and, when punctured, secrete a thin incoagulable fluid. Edema is most frequently a symptom of disease rather than a disease in itself, and it may have a number of causes, most of which can be traced back to gross variations in the physiological mechanisms that normally maintain a constant water balance in the cells, tissues, and blood. Among the causes may be diseases of the kidneys, heart, veins, or lymphatic system; malnutrition; or allergic reactions.
Moreover, bleeding (hemorrhage) can cause blood to collect and clot (hematoma). Hematomas can, for example,)occur beneath the outermost of three membranes that cover the brain (meninges) as a result of a head injury. There are two types of cranial subdural hematomas. An acute subdural hematoma occurs soon after a severe head injury. A chronic subdural hematoma is a complication that may develop weeks after a head injury. Such a head injury may have been so minor that the patient does not remember it. An epidural hematoma is a traumatic accumulation of blood between the inner table of the skull and the stripped-off dural membrane. The inciting event often is a focused blow to the head. It is often difficult to detect hematomas, particularly when the hematoma occurs well after the time of an injury.
In addition to accumulation of body fluids, elevated fluid levels in tissue can arise as a result of introduction of a fluid into the body, for example, during an injection procedure. In that regard, in many medical diagnostic and therapeutic procedures, a physician or other person injects fluid into a patient's blood vessels. Moreover, in recent years, a number of injector-actuated syringes and powered injectors for pressurized injection of contrast medium in procedures such as angiography, computed tomography, ultrasound and NMR/MRI have been developed.
Extravasation or infiltration is the accidental infusion or leakage of an injection fluid such as a contrast medium or a therapeutic agent into tissue surrounding a blood vessel rather than into the blood vessel itself. Extravasation can be caused, for example, by rupture or dissection of fragile vasculature, valve disease, inappropriate needle placement, or patient movement resulting in the infusing needle being pulled from the intended vessel or causing the needle to be pushed through the wall of the vessel. High injection pressures and/or rates of some modern procedures can increase the risk of extravasation. In computed tomography, for example, contrast injection flow rates can be in the range of 0.1 to 10 ml/s.
Extravasation can cause serious injury to patients. In that regard, certain injection fluids such as contrast media or chemotherapy drugs can be toxic to tissue. It is, therefore, very important when performing fluid injections to detect extravasation as soon as possible and discontinue the injection upon detection.
Several extravasation detection techniques are known in the art. Two simple and very useful techniques for detecting extravasation are palpation of the patient in the vicinity of the injection site and simple visual observation of the vicinity of the injection site by a trained health care provider. In the palpation technique, the health care provider manually senses swelling of tissue near the injection site resulting from extravasation. By visual observation, it is also sometimes possible to observe directly any swelling of the skin in the vicinity of an injection site resulting from extravasation.
In addition to palpation and observation, there are a number of automated methods of detecting extravasation that may include automatic triggering of an alarm condition upon detection. Unfortunately, each of these automated methods of detecting extravasation is limited by significant drawbacks.
In that regard, several plethysmographic detection techniques are available. For example, mercury strain gauge plethysmographs measure the volume change resulting from venous blood flow in a cross sectional area of a limb of a patient. Air cuff or pulse volume recorder plethysmographs measure the changes in pressure within a recording cuff. Such plethysmographs can be cumbersome to operate and/or insensitive to small changes in volume.
Impedance plethysmographs use low-frequency electromagnetic energy transmitted via galvanic contact with the skin to measure changes in the electrical impedance in a defined tissue volume of a limb. Detection of extravasation via impedance changes is disclosed, for example, in U.S. Pat. Nos. 5,964,703 and 5,947,910. In this method, an impedance change of a certain level relative to a baseline measurement in the vicinity of the injection site is interpreted as being an extravasation. A change in impedance occurs during extravasation because injection fluid in the tissue of the patient changes both the volume and the electrical impedance properties of the tissue. Use of electrodes in impedance plethysmographs can, however, result in instabilities. For example, maintaining suitable electrical (ohmic or galvanic) contact between the electrodes of impedance plethysmographs and the skin of the patient is often very difficult.
Photo-plethysmographs measure the optical scattering properties of capillary blood to detect the presence of extravasated fluids in tissue. An example of a photo-plethysmograph is described in U.S. Pat. No. 4,877,034. Because light is heavily absorbed in tissue, however, the sensitivity of photo-plethysmographs is generally limited to the top ¼ inch of tissue. Many extravasations, however, occur deeper than ¼ inch. Moreover, the injection medium may flow into interstitial spaces remote from the photoplethysmograph sensors and go undetected.
A number of extravasation detection devices attempt to measure temperature differences to determine if an extravasation has occurred. For example, U.S. Pat. No. 4,647,281 discloses subcutaneous temperature sensing of extravasation to trigger an alarm. In this method of extravasation detection, an antenna and a microwave radiometer instantaneously measure the temperature of the subcutaneous tissue at the site where fluid is injected by measuring microwave radiation emitted naturally from the body. An algorithm periodically determines the temperature difference between tissue and injected fluid, and compares the difference to a fixed threshold. An alarm processor uses the comparison to determine an alarm condition.
In addition, U.S. Pat. No. 5,334,141 discloses a microwave extravasation detection system employing a reusable microwave antenna and a disposable attachment element for releasably securing the microwave antenna to a patient's skin over an injection site. The attachment element holds the antenna in intimate contact with the patient's skin to optimize microwave transfer therebetween, while shielding the antenna from environmental noise signals. U.S. Pat. No. 5,954,668 also discloses use of a microwave antenna to sense temperature of tissue to detect extravasation. Although measurement of temperature changes and emissivity using microwave energy can result in instantaneous detection, temperature differences are often too small for practical measurement.
In addition to microwave radiometry for the detection of extravasation as described above, radiometry has also been proposed for the detection of pulmonary edema as described in U.S. Pat. No. 4,488,559. U.S. Pat. No. 4,240,445 discloses detection of pulmonary edema via transmitting electromagnetic energy through a transmission line coupled to tissue. U.S. Pat. No. 4,690,149 discloses detection of brain edema via impedance changes detected by a sensor. A proposed method of detection of brain edema is also disclosed in U.S. Pat. No. 6,233,479, in which a measured signal from a microwave antenna is compared to a stored characteristic edema signal.
Microwave energy has also been used for the detection of tumors in living tissue as described in U.S. Pat. No. 6,061,589. Unlike the passive measurements in microwave radiometry, U.S. Pat. No. 6,061,589 disclosed transmission of electromagnetic energy into the body (breast tissue) using a microwave antenna in and a resultant signal is measured. In that regard, U.S. Pat. No. 6,061,589 describes a microwave antenna to detect incipient tumors in accordance with differences in relative dielectric characteristics. Electromagnetic energy in the microwave frequency range is, applied to a discrete volume in the tissue and scattered signal returns are collected. The irradiated location is shifted or changed in a predetermined scanning pattern. The returned signals are processed to detect anomalies indicative of the present of a tumor.
Microwave energy has also been used as in non-invasive tomographic spectroscopy imaging. See U.S. Pat. Nos. 6,332,087 and 6,026,173. Microwave energy has further been used to measure the fat content in nonliving organic tissue. For example, M. Kent, “Hand Held Fat/Water Determination”, (1993), available at www.distell.com/products/papers/pap- er2.htm, discloses a microstrip sensor for such a determination. In general, the fat content of pelagic and other fatty species of fish is proportion to water content. The dielectric properties of the fish depend on the water content. In the device of Kent, changes in transmission properties of the fish were calibrated against water content.
It is desirable to develop improved devices, systems and methods for detecting changes in fluid levels in tissue, and particularly, for detecting elevated or otherwise abnormal levels of fluids in living tissue (for example, as a result of edema, hematoma or extravasation). The objectives and advantages of the invention herein presented will become fully apparent to persons skilled in the relevant art from a reading of the detailed description section of this document, and will become particularly apparent when the detailed description is considered along with the drawings and claims presented herein.